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Decitabine, Cytarabine, and Daunorubicin Hydrochloride in Treating Patients With Acute Myeloid Leukemia

NCT01627041 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2026-04-27

No results posted yet for this study

Summary

This randomized phase II trial studies how well decitabine works when given together with daunorubicin hydrochloride and cytarabine in treating patients with acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, daunorubicin hydrochloride, and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Decitabine may help daunorubicin hydrochloride and cytarabine kill more cancer cells by making them more sensitive to the drugs. It is not yet known whether low-dose decitabine is more effective than high-dose decitabine when giving together with daunorubicin hydrochloride and cytarabine in treating acute myeloid leukemia.

Conditions

  • Acute Myeloid Leukemia
  • Adult Acute Basophilic Leukemia
  • Adult Acute Monoblastic Leukemia
  • Adult Acute Monocytic Leukemia
  • Adult Acute Myeloid Leukemia With Maturation
  • Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-KMT2A
  • Adult Acute Myeloid Leukemia Without Maturation
  • Adult Acute Myelomonocytic Leukemia
  • Alkylating Agent-Related Acute Myeloid Leukemia
  • Secondary Acute Myeloid Leukemia

Interventions

DRUG

Cytarabine

Given IV

DRUG

Daunorubicin Hydrochloride

Given IV

DRUG

Decitabine

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacological Study

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Joseph M Scandura · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-16
Primary Completion
2016-02-11
Completion
2027-02-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01627041 on ClinicalTrials.gov